21/10/2016

TraceabilityMatrixforProcessValidation|IVTDocumentation

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TraceabilityMatrixforProcessValidation|IVT
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Soyouvefollowedyourvalidationplan,qualifiedalltheappropriate
equipment,anddeveloped,challenged,andplacedcontrolsonyourprocess.
Installationqualification(IQ),operationalqualification(OQ),and
performancequalification(PQ)iscomplete.Drawings,procedureshavebeenapproved.Trainingiscompleteandwell
documented.Thesummaryreportindicatesthatalltheexpectedactivitiesandtestswerecompletedsuccessfullyand
anyexceptionshavebeenappropriatelyresolved.
Youregoodtogo!
Sometimelater,maybeyearslater,anauditorshowsup.Thequestionsstart.Allhandsondeck!
Notsurprisingly,bynow,manyoftheoriginalteammembershavemovedontootherpositions.Mostoftheleaders
whoapprovedtheprotocolsandreportshavetransitionedtootherresponsibilities.Thedocumentationmuststandon
itsown.
Maybetherearecertainlinksbetweendocuments(typicallyonchangehistorypages),butovertimetheyusually
becomedifficulttofollowespeciallyifyourenotoneofthedocumentcontrolspecialists.So,ifprobingquestionsarise,
wouldntitbegreattohaveawaytofindaccurateandcompleteanswersquickly?Notareplacementforyourtechnical
file,butonedocumentthatwillbringtogetheralltheprocessdevelopment,specifications,testing,etc.thatsaligned
withyourvalidationreport.
HereiswhereIseeanopportunitytoimprovemanyprocessvalidationsystems.Takealessonfromthecomputer
systemsvalidation(CSV)group.Addatraceabilitymatrixtoyourdocumentation.
BasicallyarequirementforCSV,traceabilitymatrixesclearlyindicatetherelationshipsbetweenuserrequirements,
developmentspecifications,tests,andprocedures.Atraceabilitymatrixprovidesameansoflinkingrelevant
specificationstotestingmustbeestablishedandmaintained.Thematrixtraceseachrequirementthroughdesign,
implementationinthecode,andevaluationduringtesting.Traceabilityensuresthatrequirementsaremetandcanbe
tracedtotheappropriateconfiguration/designelements.
Andthatalltherequirementsareverifiedandcanbetracedtotestingorverificationactivitytheshowsthatthe
requirementhasbeenmet.
Thisconceptcaneasilybeadoptedtoshowtherelationshipsbetweenproductionspecifications,riskanalysis,IQ,OQ,
PQtests,andtheproceduresestablishedtomaintainthevalidatedstateofyourprocess.Bestofall,itcanbenavigated
bypeoplenotintimatelyfamiliarwiththeprocesstofindallthedocumentationassociatedwithanyspecificelementof
thatprocess.
Ofcourse,inpractice,eachcellinthisgenericexamplewouldbepopulatedwiththeappropriatedocument
identificationnumber.Besuretoincludetheversionnumber.Manyofthedocumentswillchangeovertime,andyou
wanttorefertotheversionthatwasineffectatthetimeofthevalidation.

Product
Specification

DOE

Critical
Input

SealIntegrity
Specification

CriticalInputs Heat
Process
Parameters

Controllers

Challenges,Checks,andBalances

Heating
Element

IQ

PM

Temperature IQ/OQ
Controller

Calibration

Temperature DOE
Setttings

DOE

Setup Operating Training

Sheets Procedures

Whileyoucouldstartfurtherbackinthedevelopmentprocess,itseemstomakesensetostartwithyourfinalproduct
specificationsthatwillbeusedformanufacturing.Thencreateamapfromeachspecificationthroughdesignof
experiment(DOE),equipmentqualifications,challengetesting,andrundocumentation.

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TraceabilityMatrixforProcessValidation|IVTDocumentation
Atsomepoint,youwillbeabletocreateastandardtemplateforthematrix.Thenyoucanusethematrixintwoways.
Thefirstwouldbetoshowwhereorhoweachprocesselementwasdeveloped,tested,andcontrolled.Secondly,itcould
alsobeusedasanaudittooltoclearlyshowthateachelementwasfullyvalidated.

PRINTERFRIENDLYVERSION

Tags:Documentation,ProcessValidation

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